GDPMD is a regulatory requirement that affects parties involved in the distribution of medical devices, from manufacturers, wholesalers, importers and exporters as well as distributors, regardless of business size. GDPMD specifies the requirements for a quality system to be established and maintained effectively to maintain safety and performance of medical devices throughout the supply-chain. This is an audited system that affects the organisation license to operate.

GDPMD also aims to provide a clear legal framework which identifies responsibilities and accountability of all stakeholders throughout the supply chain. As part of the regulatory requirements, stakeholders need to have the appropriate procedures, personnel, processes, facilities, equipment and documentation in place.

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